NCT00099060

Lapatinib in Treating Patients With Recurrent Glioblastoma Multiforme

A Phase I/II Study of GW572016 in Patients With Recurrent Malignant Glioma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of lapatinib and to see how well it works in treating patients with recurrent glioblastoma multiforme.

Detailed description

OBJECTIVES: Phase I * Determine the maximum tolerated dose and recommended phase II dose of lapatinib in patients with recurrent malignant glioblastoma multiforme who are taking CYP3A4 enzyme-inducing anti-epileptic drugs (EIAEDs). * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Phase II * Determine the efficacy of this drug, in terms of objective tumor response rate, in patients who are taking EIAEDs and in those who are not taking EIAEDs. * Correlate immunohistochemical measures of cellular proteins and receptors from tumor samples with anti-tumor activity of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral lapatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of lapatinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive lapatinib as in phase I at the MTD. Patients are followed at 1 month and then periodically for survival. Patients with stable or responding disease who go off therapy are followed every 3 months for up to one year and then periodically thereafter for survival. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the phase I portion of this study within 18 months. A total of 15-30 patients will be accrued for the phase II portion of this study within 18 months.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate	For patients receiving enzyme inducing anti-epileptic drugs (EIAEDs): * Phase I: starting dose for first cohort: 1000 mg GW572016 po b.i.d.; actual dose assigned at registration; intra patient dose escalation permitted ONCE in phase I patients ONLY if specified criteria met (see section 8.6). * Phase II: Recommended phase II dose from phase I portion of the study, given po b.i.d. For patients NOT receiving enzyme inducing anti-epileptic drugs (NON-EIAEDs): • Phase II: 750 mg GW572016 po b.i.d. For all patients: • Dose reductions as required based on adverse events.

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2004-12-09
• Last updated: 2014-01-27

Locations

6 sites across 1 country: Canada